Method and apparatus for producing a filled sbm bottle

Abstract

The present invention relates to: a sterilised container which is filled with an infusion solution; a method; and a plant for producing the sterilised container. The method comprises: providing a preform, which has a hanger arranged on a base of the preform and has a connection flange, located in a head region of the preform, for welding to a closure cap; heating up the provided preform in a heating device; feeding the heated-up preform into a stretch-blow apparatus; stretching and blowing the preform in the stretch-blow apparatus so that the container for the infusion solution is shaped from the preform; cleaning the shaped container and optionally drying the cleaned container in a drying device; filling the cleaned and optionally dried container in a filling plant at least with an infusion solution via a filling opening in the container; providing a closure cap for sealing the container using a connection ring, located on the lower face of the closure cap, for welding to the container; heating a lower face of the connection ring of the closure cap and an upper face of the connection flange of the container formed from the preform to a welding temperature; sealing the container by applying the closure cap to the filling opening of the container by pressing the heated lower face of the connection ring of the closure cap onto the heated upper face of the connection flange of the container so that the closure cap and the container become materially bonded together; sterilising the sealed container in an autoclave; characterised in that the upper face of the connection flange of the container is heated by a first hot air flow and the lower face of the connection ring of the closure cap is heated by a second hot air flow, wherein the first hot air flow is conducted by a preferably heated tool upper part towards the lower face of the connection ring of the closure cap and the second hot air flow is conducted by a preferably heated tool lower part towards the upper face of the connection flange of the container. The method according to the invention allows the closure cap to be reliably connected to the container. An intimate connection is formed between the fused-on joining parts. The interior of the container is hermetically sealed.

Description

[0001] Method and device for producing a filled SBM bottle

[0002] The present invention relates to a sterilized container filled with an infusion solution, a method and a system for producing the sterilized container.

[0003] Containers for liquids used in medical applications must meet specific requirements, particularly regarding sterility. For example, bottles made of extruded PE are known, which are stretched and blow-molded into the desired shape, filled, and then hermetically sealed in a single step (blow-fill-seal process).

[0004] Liquids for medical applications include, for example, infusion solutions or parenteral nutrient solutions.

[0005] WO 2013 / 044085 A1 describes a method and system for producing an infusion container with a ring-shaped hanger at the bottom of a bottle. The bottle is manufactured from a preform by stretching and blowing it (stretch-blow-molding, or SBM). The preform itself is manufactured together with the ring-shaped hanger using an injection molding process. To maintain the sterility of the medicinal fluid, the container must be hermetically sealed with a cap.

[0006] Against the background described above, the present invention is based on the object of reliably and simply producing a container for an infusion solution using stretch blow molding and securely sealing it with a closure cap. This object is achieved by the subject matter having the features according to the independent patent claims. Advantageous embodiments are the subject of the description, the figures, and the dependent claims.

[0007] In detail, the present invention is described by methods for producing a container filled with an infusion solution comprising the following process steps:

[0008] Providing a preform with a hanger arranged at a bottom of the preform and a connecting flange arranged in a head region of the preform for welding to a closure cap,

[0009] Heating the provided preform in a heating device,

[0010] Feeding the heated preform into a stretching and inflating device,

[0011] Stretching and inflating the preform in the stretching and inflating device so that the container for the infusion solution is formed from the preform,

[0012] Rinsing the molded container, in particular with WFI (Water for Injection), and if necessary drying the cleaned container in or with a drying device,

[0013] Filling the rinsed and, if necessary, dried container via a filling opening provided in the container with at least one infusion solution in a filling system,

[0014] Providing a closure cap for closing the container with a connecting ring arranged on an underside of the closure cap for welding to the container,

[0015] Heating a bottom side of the connecting ring of the closure cap and a top side of the connecting flange of the container formed from the preform to a welding temperature,

[0016] Closing the container by applying the closure cap to the filling opening of the container by pressing the heated underside of the connecting ring of the closure cap onto the heated upper side of the connecting flange of the container so that the closure cap and the container are firmly bonded together,

[0017] Sterilizing the sealed container in an autoclave,

[0018] The manufacturing method is particularly characterized in that the heating of the underside of the connecting ring of the closure cap and the upper side of the connecting flange of the container formed from the preform to a welding temperature is carried out in such a way that the upper side of the connecting flange of the container is heated at least in sections by a first hot air stream and the underside of the connecting ring of the closure cap is heated at least in sections by a second hot air stream, wherein the first hot air stream is guided through a preferably heated upper part of the tool in the direction of the underside of the connecting ring of the closure cap and the second hot air stream is guided through a preferably heated lower part of the tool in the direction of the upper side of the connecting flange of the container.

[0019] The method according to the invention enables the reliable closure of an infusion bottle manufactured using SBM. Even in the event of pressure fluctuations during autoclaving, the inventively welded cap ensures a tight seal.

[0020] In a first embodiment, the first hot air stream is directed through a first annular nozzle in the upper tool part towards the underside of the connecting ring of the closure cap and / or the second hot air stream is directed through a second annular nozzle in the lower tool part towards the top side of the connecting flange of the container. By using annular nozzles, the first air stream and / or the second air stream can be directed specifically to the corresponding connecting regions on the closure cap or on the container. The annular nozzle according to the invention is preferably provided by a continuous annular gap. However, an annular nozzle can also be provided by a discontinuous annular gap, for example, by annularly arranged individual nozzles, as long as heating or melting of the connecting regions is such that a hermetic seal is enabled during welding.

[0021] In one embodiment, the first annular nozzle has a cross-section that increases toward an air outlet side, here in particular the top side. This allows the entire underside of the connecting ring to be reliably heated. Preferably, the first annular nozzle is inclined toward the outside. This assists in the discharge of the first air stream after the connecting ring has been heated. For this purpose, the first annular nozzle is preferably formed by an inner wall that runs essentially vertically and by an oblique outer wall that slopes toward the outside.

[0022] In a further embodiment, the second annular nozzle, in particular an axis of the second annular nozzle, is inclined inward. The air channel in the second annular nozzle is not directed vertically downward, but rather inclined inward. Thus, the air flow is also directed inward. This allows the second hot air jet to be directed inward toward the wall / connecting flange transition. There, the second air flow is redirected. This then flows along the upper side of the connecting flange, heats it, and then flows outward.

[0023] One embodiment of the welding tool is characterized in that a temperature of the first hot air stream and a temperature of the second hot air stream can be set, preferably regulated, independently of one another. This allows the temperatures to be individually adapted to the requirements of the closure cap and the container. In particular, the necessary temperatures can be adapted to the corresponding welding temperatures of the materials used in the cap and / or the container. In particular, the upper tool part and the lower tool part can be heated independently of one another. In a further embodiment, the upper tool part and / or the lower tool part can additionally be heated in sections. Preferably, the first annular nozzle and / or the second annular nozzle can be electrically heated at least in sections.This allows cooling of the first and / or second air stream to be at least reduced or compensated. This allows heating times and thus welding times to be reduced. In one embodiment, a temperature of the first annular nozzle and a temperature of the second annular nozzle can be adjusted independently of one another, preferably adjustable and / or controlled.

[0024] Preferably, the upper tool part and the lower tool part together form the heating device or the welding tool. The upper tool part and the lower tool part are arranged, in particular, on a common mounting plate. In particular, they can only be moved together, for example, on the common mounting plate. The upper tool part and the lower tool part are thermally insulated or decoupled from each other, preferably with an insulating disc or layer, so that any temperature influence from the upper tool part to the lower tool part, or vice versa, is reduced.

[0025] The invention also includes a system for filling a container or for producing a filled container with an infusion solution, comprising:

[0026] A device for providing a preform, in particular with a hanger arranged on a base of the preform, a heating device for heating the provided preform, a device for stretching and inflating the heated preform so that the container for the infusion solution can be formed from the preform, in particular a device for cleaning the formed container, preferably a rinsing device, and optionally a device for drying the cleaned container, a filling system in which the, in particular cleaned or rinsed and optionally dried, container can be filled with at least one infusion solution via a filling opening provided in the container, a device for closing the container with a

[0027] Closure cap, an autoclave or generally a sterilization device in which the closed container can be sterilized, and wherein the device for closing the container with the closure cap comprises a hot-air welding tool which is formed by an upper tool part and a lower tool part, in which a first hot air stream can be guided through the, preferably heatable, upper tool part in the direction of an underside of a connecting ring of the closure cap and a second hot air stream can be guided through the, preferably heatable, lower tool part in the direction of an upper side of a connecting flange on the container.

[0028] It is not explicitly mentioned here, but transport devices can also be provided which enable the transport of the preform and / or the empty container and / or the filled container and / or the closed container and / or the sterilized container in the system according to the invention.

[0029] In one embodiment of the invention, the welding tool comprises a first heating device for providing the first hot air stream in the upper tool part and a second heating device for providing the second hot air stream in the lower tool part. The first heating device and the second heating device are preferably designed to be separately or independently controllable and / or regulated. This allows the temperatures to be individually adapted to the requirements of the closure cap and the container. In particular, the required temperatures can be adapted to the corresponding welding temperatures of the materials used in the cap or container.

[0030] Preferably, the upper tool part and the lower tool part together form a heating device and can therefore only be moved together. In one embodiment, the upper tool part comprises a first annular nozzle and / or the lower tool part comprises a second annular nozzle. This allows the first air flow and / or the second air flow to be directed specifically to the corresponding connection areas on the closure cap or the container.

[0031] The first hot air stream is heated by the first heating device. The second hot air stream is heated by the second heating device. To prevent or reduce cooling of the first and / or second air stream, one embodiment provides a further, separate heating device. For this purpose, the first annular nozzle can be electrically heated, at least in sections, by a first, secondary heating device and / or the second annular nozzle can be electrically heated by a second, secondary heating device.

[0032] According to the invention, the closure is provided as a closure cap. In particular, the closure cap and / or the filling opening of the container is / are heated at least in sections, whereby the container is closed by welding the closure cap onto the filling opening of the container. Preferably, the closure cap is manufactured by injection molding.

[0033] Finally, the following method steps can be carried out on the container: checking the sterilized container in an inspection device and / or applying a label to the inspected container and / or arranging a plurality of labeled containers in a carton and closing the carton. The oval and not circular basic shape of the container allows a high packing density to be achieved. For example, the checking comprises at least one, preferably camera-based, visual inspection and / or a leak test and / or a fill level measurement, preferably by weighing. The method steps according to the invention described above can also be implemented by corresponding devices that are designed or suitable for carrying out the described method steps.

[0034] The scope of the invention also includes a sterilized container with a base body stretched from a preform, inflated and filled with an infusion solution, which merges upwards via a shoulder region into a bottle neck with a filling opening, which is closed with a closure, and merges downwards into a base region.

[0035] In one embodiment, an upper first flange, in particular for guiding the closure when placed on the bottle neck, and a second lower flange, which has a larger diameter than the first flange, for connecting the closure to the container are provided in the region of the bottle neck. This can assist in the placement and connection of the closure.

[0036] Preferably, in the region of the bottle neck between the first flange and the second flange, an upper first recess and a second recess below the first recess, by means of which the container can be gripped and / or transferred, are provided. This can simplify the handling of the not yet closed and / or closed container, for example by means of a gripper. The section directly below the second flange, which is also described here as the connecting flange, the upper side of which is melted for welding to the closure cap, is gripped by the container gripper during welding. This preferably supports the connecting flange over its entire surface during welding.

[0037] The present invention also encompasses the use of the system described above for producing a container filled with an infusion solution and closed with a closure cap. The present invention also encompasses the use of the device according to the invention for closing a container with a closure cap for closing a container filled with an infusion solution. The device for closing the container with the closure cap comprises a hot-air welding tool formed by an upper tool part and a lower tool part, in which a first hot air stream can be guided through the preferably heatable upper tool part towards an underside of a connecting ring of the closure cap and a second hot air stream can be guided through the preferably heatable lower tool part towards an upper side of a connecting flange on the container.

[0038] Furthermore, the invention also encompasses a preform for producing the above-described container according to the invention. The preform is preferably produced by injection molding.

[0039] The method according to the invention can be carried out in particular using the system according to the invention. The system according to the invention is particularly designed to carry out the method according to the invention. The sterilized container according to the invention can be produced or is produced using the method according to the invention. The sterilized container according to the invention can be produced or is produced from the preform according to the invention.

[0040] The container can, for example, have a capacity of approximately 100 ml to approximately 1000 ml. The system and / or the method and / or the sterilized container according to the present invention can be used in particular for infusion solutions or also generally for medicinal liquids. The medicinal liquid is a liquid used for medical purposes. In a preferred embodiment, the medicinal liquid is an infusion solution. Possible examples of such infusion solutions include sterile water; saline solutions; in particular solutions containing NaCl, KCl, CaCl, and / or Mg; solutions containing carbohydrates, in particular glucose solutions; solutions containing nutrients for parenteral nutrition and / or colloid solutions, in particular for blood replacement therapy (e.g., Voluven).

[0041] In a preferred embodiment of the invention, the container is a bottle, in particular a plastic bottle. The bottle comprises the hanger, a base region, a base or bottle body, a shoulder region, and a bottle neck.

[0042] In a preferred embodiment, the material for the preform, the container made from the preform, and / or the closure cap is or comprises polypropylene. The polypropylene is preferably manufactured according to Ph. Eur. 3.1.6 (EUROPEAN PHARMACOPOEIA). This material is sterilizable at 121°C. Furthermore, the material can be used in both an injection molding process and a stretch blow molding process. Furthermore, this material exhibits good gas and water impermeability.

[0043] In addition, a container filled and sterilized with a clear liquid, preferably with a clear infusion solution, has excellent, glass-like transparency, especially in its jacket area or bottle belly.

[0044] The present invention will be explained in detail using the following exemplary embodiments. Reference is made to the accompanying drawings containing schematic representations. The same reference numerals in the individual drawings refer to the same parts.

[0045] Fig. 1 shows an embodiment of the inventive

[0046] Method and the system according to the invention in a block diagram;

[0047] Fig. 2.a and 2.b show an embodiment of a preform according to the invention in a side view (Fig. 2.a) and in a cross-section (Fig. 2.b); Fig. 3.a to 3.e show an embodiment of a filled container according to the invention in a side view (Fig. 3.a), in a perspective view (Fig. 3.b), in a plan view of the underside (Fig. 3.c) and the top side (Fig. 3.d), and in a side view with the closure cap in place (Fig. 3.e);

[0048] Fig. 4.a to 4.c show an embodiment of a cap according to the invention for closing the container in a side view (Fig. 4.a), a side view rotated by 90° (Fig. 4.b) and in a cross-section (Fig. 4.c);

[0049] Fig. 5.a to 5.d show a detailed view of the connection area on the container 200 in a cross-section: Fig. 5.a along the depth of the container, Fig. 5.b along the width of the container, Fig. 5.c an enlarged view of the area A from Fig. 5.a. and Fig. 5.d an enlarged view of the area C from Fig. 5.c;

[0050] Fig. 6. a to 6.d illustrate individual process steps in the welding process, in the preparation of the closure cap and container (Fig. 6.a), in the heating of the closure cap and container (Fig. 6.b) and in the joining of the closure cap and container (Fig. 6.c) as well as a schematic cross-section of the formed connection area or the formed weld seam (Fig. 6.d); and

[0051] Fig. 7. a to 7.c show a detailed view of the welding tool, the entire welding tool (Fig. 7.a), the upper part of the welding tool with the attached closure cap and the lower part of the welding tool with the attached container (Fig. 7.c).

[0052] First, Figure 1 provides an overview of the method and an associated system for producing a container 200 filled with an infusion solution. The container 200 is embodied here as a bottle. In a first step S100, the preforms 100 are provided. This is done by a device for providing a preform 100. An example of such a device is a robot arm with a gripper. The preforms 100 each have a hanger 150 at their base.

[0053] In a next step S200, the preforms 100 are heated in a heating device 10. The heating device 10 can be provided, for example, by a preferably electric radiant heater. The preforms 100 are first heated such that each preform 100 is or will be heated substantially uniformly. This is followed, for example, by preferential heating of individual subregions of the preforms 100. In this case, the heating is such that the preforms 100 are no longer heated uniformly thereafter and can expand differently during the subsequent stretching and inflation. This is particularly advantageous in the production of non-rotationally symmetrical, for example oval, containers. Before the preferential heating, the preforms 100 can be aligned according to the orientation of the hangers 150.In a next step S300, the hangers 150 of the preforms 100 are bent by a bending device 30.

[0054] The heated preforms 100 are fed to a stretch-blow molding device 40. In a step S400, the containers 200 are formed by stretching and inflating the preforms 100. In a next step S500, the molded containers 200 are rinsed or cleaned, for example, in a rinsing device, and optionally the cleaned containers are dried, for example, by means of an air flow and / or heat.

[0055] The rinsed or cleaned, and optionally dried, containers 200 are filled with an infusion solution in a next step S600. Filling takes place via a filling opening 115 provided in the container 200, here via an open bottle neck 210, in a filling system. The filled containers 200 are then sealed (step S700), according to the invention by applying a closure cap 300 to the filling opening 211 of the container 200. The closure cap 200 is welded on. In a next step S800, the sealed containers 200 are sterilized, for example, in an autoclave. After sterilization, the containers 200 and the liquids contained therein are particularly suitable for infusion applications.

[0056] Finally, the sterilized container 200 may be inspected in an inspection device, the containers 200 may be labeled, the labeled containers 200 may be placed in a carton, and / or the carton may be sealed. This is summarized in step S900. The inspection includes, for example, a visual inspection, preferably using a camera, a leak test, preferably using a pressure cuff, and / or a fill level measurement, preferably using a scale.

[0057] Transport devices for transferring the preform 100 and / or the empty container 200 and / or the filled container 200 and / or the sealed container 200 and / or the sterilized container 200 are not shown in the figures. Such transport devices can, for example, be in the form of a robot arm with a gripper and / or a conveyor belt with holders and / or a rotary conveyor with gripping elements. An example of a transport device and an embodiment for heating and aligning the preform 100, folding the hanger 150 on the preform 100, and feeding the preform 100 into the mold 40 for stretching and inflation is shown in patent application WO 2013 / 044085 A1 (see in particular Figures 2.a and 2.b therein). In this regard, the content thereof is incorporated in its entirety by reference into the present patent application.

[0058] The following figures first describe the individual components of an infusion bottle 200 in concrete terms. As a starting point, a preform 100 is shown in Figures 2a and 2b. The preform 100 is a body open at the top. The hanger 150 is arranged on the underside of the preform 100. The preform 100 and the hanger 150 are formed as a single piece. They are manufactured as a single body by injection molding. Preferably, the preform 100, disregarding the hanger 150, is a substantially rotationally symmetrical body. Such a body can be manufactured quite easily and thus cost-effectively by injection molding. In this embodiment, the preform 100 shown essentially comprises five regions.

[0059] An upper first region 110, comprising the opening 115, which then forms the container or bottle neck 210. This region is essentially not inflated. It essentially retains its original wall thickness. The opening 115 forms the inlet opening or opening in the bottle neck 210 of the container 200 to be formed from the preform 100. The opening 115 has a diameter of approximately 12 mm to approximately 38 mm. A first flange 111 and a second flange 112 are arranged below the opening 115.

[0060] This creates a first recess 113 between the two flanges 111 and 112. The second flange 112, located toward the bottom, is wider than the upper first flange 112. The second flange 112 serves to rest on the mold during stretching and inflation. Furthermore, the second flange 112 serves as a contact surface for welding to a closure cap 300 (see the description of Figures 6.a to 7.c). Below the second flange 112, a second recess 114 is located in the outer side of the preform 100. The two recesses 113 and 114 are essentially not stretched and inflated, as they are then arranged in the region of the bottle neck 210. The first and second recesses 113 and 114 simplify the handling of the preform 100 and the molded container 200.For example, a gripper can securely hold the preform 100 via the first recess 113 and transfer it to a second gripper, which can then hold and receive the preform 100 via the second recess 114. The wall thickness here, for example, is in a range from approximately 1 mm to approximately 4 mm. The length of the first region 110 in the direction of the central axis L is approximately 20 mm to approximately 30 mm. It is essentially independent of the overall size of the preform 100.

[0061] Furthermore, the preform 100 comprises a second region 120 adjoining the underside, which then forms the shoulder region 220 of the container 200. This region is at least partially inflated. The shoulder region 220 of the formed container 200 then has a wall thickness that decreases, at least in sections, from the bottle neck 210 to the third region 220. The wall thickness of the preform 100 increases in the second region 120 from the wall thickness in the first region 100 to the wall thickness in the third region 130. The length of the second region 120 in the direction of the central axis L is approximately 5 mm to approximately 10 mm. The length is essentially independent of the overall size of the preform 100.

[0062] The third region 130 adjoins the underside and then forms the base body 230 of the container 200. This third region 130 is essentially completely inflated for this purpose. It then has the thinnest wall thickness in the formed container 200. However, this wall thickness is not uniform because the preform 100 is heated to different intensities and is therefore stretched to different degrees during inflation (see the description of Figures 3.a to 3.c). The wall thickness here in the third region 130 of the preform 100 is greater than the wall thickness in the first region 110. The wall thickness of the preform 100 is essentially constant over its circumference and in height in the third region 130. Here, for example, it is in a range from approximately 2 mm to approximately 3.5 mm. The preform itself has a tapered cross-section in this section. The length of the third region 130 in the direction of the central axis L is approximately 80 mm to approximately 250 mm.The length of the third region 130 is selected depending on the size of the container 200 to be formed. With this length range, containers 200 can be produced with a capacity of approximately 100 ml to approximately 1000 ml. Furthermore, the fourth region 140 adjoins the underside, which then forms the bottom region 240 of the container 200. This fourth region 140 is at least partially inflated. The bottom region 240 of the formed container 200 has a wall thickness that increases, at least in sections, from the base body 230 to the bottom 240. The wall thickness of the preform 100 is smaller than the wall thickness in the third region 130. Here, it lies, for example, in a range from approximately 1 mm to approximately 2 mm. The length of the fourth region 140 in the direction of the central axis L is approximately 15 mm to approximately 30 mm. The length is essentially independent of the overall size of the preform 100.

[0063] The hanger 150 is arranged on the bottom region 140 or on the underside of the preform 100. The hanger 150 forms the fifth region 150. The hanger 150 is, for example, a closed hanger. It is not inflated. Its wall thickness is, for example, in a range of 1 mm to 3 mm. The hanger 150 is connected to the bottom 140 or the underside 140 of the preform 100 and later to the formed container 200 via a transition region 145. The transition region 145 has a smaller wall thickness. Here, it is, for example, in a range of approximately 0.3 mm to approximately 1.5 mm. The transition region 145 is flexible. The hanger 150 is thus arranged so that it can be pivoted or bent. The transition region 145 provides a type of film hinge. Preferably, the transition 145 is rounded on both sides along the axis QH. To further improve the mobility of the hanger 150, two lateral notches 146 are provided.Preferably, these lateral notches 146 are rounded at their respective apex (see Figure 2.b). This can further improve the flexibility of the hanger 150.

[0064] The length of the hanger 150 in the direction of the central axis LH is approximately 20 mm to 30 mm. Along its transverse axis QH, the hanger 150 has a width which, starting from the transition 145 along the longitudinal axis LH, initially increases and then decreases again. This provides, on the one hand, the required transition 145 and, on the other hand, a sufficiently large stop surface for the bending device 30 to fold the hanger 150. The maximum length of the hanger 150 in the direction of its transverse axis QH is approximately 20 mm to 30 mm. The length and / or the width are essentially independent of the overall size of the preform 100.

[0065] The container 200 formed from the preform 100 is a plastic bottle. The bottle 200 has a bottle neck 210, a shoulder portion 220, a base or bottle body 230, a bottom portion 240, and the hanger 150. The container 200 can, for example, have a capacity of approximately 100 ml to approximately 1000 ml.

[0066] Figures 3.a to 3.d show different views of a formed and filled, but not yet sealed, container 200. The shape of the formed body essentially reflects the shape of the mold in which the preform 100 was inflated. Figure 3.e shows the finished container 200 with the welded cap 300.

[0067] The container 200, like the preform 100 from which the container 200 was formed, comprises five regions. An upper first region 210 comprising the opening 115, which then forms the container or bottle neck. This region has essentially not been inflated. It has essentially retained the original wall thickness and the structures of the preform 100, for example, the first flange 111, the second flange 112, the first recess 113, and / or the second recess 114, in this region.

[0068] The container 200 further comprises a second region 220 adjoining the underside, which then forms the shoulder region of the container 200. This region is at least partially inflated. The shoulder region 220 of the formed container 200 then has a wall thickness that decreases, at least in sections, from the bottle neck 210 to the third region 230. Due to the inflation, the wall thickness of the preform 100 now decreases from the wall thickness in the first region 210 to the wall thickness in the third region 230. Adjoining the underside is the third region 230, which forms the base body 230 or bottle body 230 of the container 200. In this section, the container 200 has, at least in sections, a substantially elliptical cross-section. The container is wider than it is deep. This third region 230 has been substantially fully inflated. It now has the thinnest wall thickness in the formed container 200.However, it is not uniform across the circumference because the preform 100 was heated to different degrees and thus stretched to different degrees during blow molding. The sides that provide the longer width B of the container 200 are, at least in some sections, thinner than the sides of the container 200 that provide the shorter depth T of the container 200.

[0069] Furthermore, the fourth region 240 adjoins the underside, forming the bottom region 240 of the container 200. This fourth region 240 has been at least partially inflated. The bottom region 240 of the molded container 200 has a wall thickness that increases, at least in sections, from the base body 230 to the bottom 240. The wall thickness of the container 200 in the fourth region 240 is greater than the wall thickness in the third region 230.

[0070] The hanger 150 is arranged at the bottom region 240 or at the bottom 240 of the container 200. The hanger 150 forms the fifth region 250. It is not inflated. It has essentially retained its properties.

[0071] At least one support foot 241 is arranged or formed around the circumference of the hanger 150. For example, four support feet 241 are formed in the base area 240.

[0072] A preferred embodiment of a closure 300 for closing the container 200 is shown in Figures 4.a to 4.c. The closure 300 is designed as a closure cap. It is placed on the bottle neck 210 of the container 200 and hermetically seals the interior of the container 200.

[0073] The closure cap 300 here has, for example, two accesses 301 and 302 to the interior of the container 200. A first access 301 for removing a liquid, preferably by means of a spike, and a second access 302 for adding a liquid, for example an active ingredient to be diluted. The two accesses 301 and 302 are preferably each closed with a sealing element shown in the figure and with a tamper-evident closure. The two tamper-evident closures are each designed, for example, as a break-off and / or twist-off part with corresponding arrows as markings for removal or addition. After removing the two tamper-evident closures, the two sealing elements can be wiped clean on their upper sides, for example with a sterile wipe.

[0074] According to the invention, the closure cap 300 is welded to the container 200. When the closure cap 300 is placed on the container, the inner edge 303 comes into contact with the second flange 112 of the container 200. The first flange 111 can serve as a guide during placement. For this purpose, at least the inner edge 303 of the closure cap 300 and the second flange 112 of the container 200 are heated accordingly and welded together. The inner edge 303 of the closure cap 300 is also referred to below as the connecting ring 303. The second flange 112 of the container 200 is also referred to below as the connecting flange 112.

[0075] The inner connecting ring 303 has an inner diameter of approximately 28 mm to 32 mm and / or an outer diameter of approximately 30 mm to 34 mm. The wall thickness of the connecting ring 303 is 0.5 mm to 1.3 mm, preferably 0.7 mm to 1 mm. The outer shielding ring 304 has an inner diameter of approximately 35 mm to 40 mm and / or an outer diameter of approximately 36 to 40 mm. For example, the wall thickness of the shielding ring 304 is in a range of 0.5 mm to 0.75 mm. The outer shielding ring 304 extends downward beyond the connecting ring 303. The underside of the shielding ring 304 is 0.1 mm to 0.4 mm lower than the underside of the connecting ring 303.

[0076] The inner connecting ring 303 represents a kind of extension of the wall of the closure cap 300. In contrast, the outer shielding ring 304 is formed on the outside of the closure cap 300 via a kind of step or flange. This creates an annular gap 305 between the connecting ring 303 and the shielding ring 304. The gap 305 can assist in the removal of hot air after the connecting ring has been heated. After the connecting ring has been heated, the air is redirected there and directed outwards. This can be further assisted by rounding the inner edges of the gap or annular gap 305, as shown. In the present case, the annular gap 305 has a width of 1.5 mm to 2 mm and a depth, relative to the underside of the cover ring 304, of 2.0 mm to 3.0 mm.

[0077] Figures 5.a to 5.d. show a detailed view of the connection area on the container 200 or the bottle 200 in a cross-section. Figure 5.a shows the cross-section along the depth of the container 200, and Figure 5.b shows the cross-section along the width of the container 200. Figure 5.c shows an enlarged view of area A from Figure 5.a. Figure 5.d shows an enlarged view of area C from Figure 5.c.

[0078] The upper flange 111 can serve to guide the cap 300 when it is placed on the bottle 200 and is also referred to below as the guide flange 111. The upper flange 111 has a diameter of 28 to 32 mm. The upper flange 111 has a smaller diameter than the lower connecting flange 112. The connecting flange 112 preferably has an outer diameter of 34 mm to 38 mm.

[0079] The outer wall of the bottle neck has an outer diameter of approximately 26 mm to 30 mm. This allows the connecting flange 112 to provide a step width of 3 mm to 5 mm. The thickness or height of the connecting flange 112 is 1 mm to 3 mm. The thickness of the step is selected such that, on the one hand, sufficient mechanical stability is provided when connecting to the closure cap 300 and, on the other hand, that sufficient material is available for welding. The welding process is illustrated in Figures 6.a to 6.d.

[0080] In a first step (Figure 6.a), the cap 300 is held by a cap gripper 310 and the bottle 200 by a bottle gripper 320. The cap gripper 310 grips the cap 300 on its outer side. The flange gripper 320, which can also be a type of bottle carrier, supports the bottle 200 below the connecting flange 112.

[0081] In a second step (Figure 6.b), the welding tool 700, which is initially only shown schematically here, is positioned between the cap 300 and the bottle 200, and the cap and bottle are brought towards the welding tool, but without touching them. For example, the underside of the welding tool 700 can first be brought against the bottle 200, and then the cap 300 can be brought against the top of the welding tool 700. The welding tool 700 does not come into contact with the connecting or welding areas of the bottle 200 and the cap 300. The welding tool 700 heats, preferably simultaneously, the connecting ring 303 on the cap 300 and the connecting flange 112 on the bottle 200. The two connecting areas 303 and 112 are each heated to such an extent that they are at least partially melted and, when the two areas are pressed together, form a materially bonded connection.

[0082] In a next step, the welding tool 700 is removed and the closure cap 300 is placed on the bottle 200, pressed on, and welded together (Figure 6.c). The inner connecting ring 303 of the closure cap 300 and the connecting flange 112 of the bottle 200 form a materially bonded connection. The interior of the bottle 200 is hermetically sealed. Preferably, the base region of the connecting ring 303 penetrates into the connecting flange 112 during the connection and pressing process and, in particular, also expands into a mushroom shape (see Figure 6.d). In particular, the mushroom shape formed has a width corresponding to 1.2 to 1.8 times the wall thickness (dK) of the connecting ring 303 and / or a longitudinal extent corresponding to 0.3 to 0.6 times the thickness (df) of the connecting flange 112.

[0083] Figures 7.a. to 7.c now show a detailed view of the welding tool 700 according to the invention. The welding tool 700 according to the invention is a hot-air welding tool, which can preferably also be heated in sections, preferably electrically.

[0084] The welding tool 700 is formed from an upper tool part 710 and a lower tool part 720. The upper tool part 710 and the lower tool part 720 together form the heating device and can only be moved together. They are spatially fixed to one another. However, the upper tool part 710 and the lower tool part 720 can be heated independently of one another. This allows the temperature to be individually adjusted to the temperature requirements of the closure cap 300 and the bottle 200. The upper tool part 710 and the lower tool part 720 are thermally insulated or decoupled from one another, so that any temperature influence from the upper tool part 710 to the lower tool part 720, or vice versa, is reduced. The upper tool part 710 and the lower tool part 720 are mounted here on a mounting plate 730, which optionally has upper and / or lower insulation.

[0085] For this purpose, a first heating device 810 is assigned to the upper tool part 710, via which a first hot air stream can be supplied to the upper tool part 710. The first heating device 810 preferably comprises a first electrical heater, which heats an air stream generated by a compressor. This is, for example, a first hot air generator. The air stream is provided, for example, at a temperature of approximately 550 to 650°C. The air is provided as sterile air, which has been sterilized, for example, by a sterile filter. The strong heating of the air ensures that the sterility of the air is maintained. In addition to the first heating device 810, a separate, secondary first electrical heating device 812 is assigned to the upper tool part 710. The secondary first electrical heating device 812 is used here to heat the upper annular nozzle 713, preferably in sections (see Figure 7.b).

[0086] Associated with the lower tool part 720 is a second heating device 820, which can be adjusted separately or independently of the first heating device 810 and via which a second hot air stream can be supplied to the lower tool part 720. The second heating device 820 comprises a preferably electric heater that heats an air stream generated by a compressor. This is, for example, a second hot air generator. The air stream is provided, for example, at a temperature of approximately 550 to 650°C. The air is provided as sterile air, which has been sterilized, for example, by a sterile filter. The strong heating of the air ensures that the sterility of the air is maintained.

[0087] In addition to the second heating device 820, a separate secondary second electrical heating device 822 is assigned to the lower tool part 720. The secondary second electrical heating device 822 is used here to heat the lower annular nozzle 723, preferably in sections (see Figure 7.c).

[0088] Further details on the upper tool part 710 and the lower tool part 720 are explained below in the description of Figures 7.b and 7.c.

[0089] Figure 7.b shows the upper tool part 710 with the closure cap 300 to be heated brought towards it. The closure cap 300 is brought towards the upper tool part 710 via the closure gripper 310. The first heating device 810, via which a first hot air stream can be supplied to the upper tool part 710, is assigned to the upper tool part 710. The direction of the first hot air stream is indicated by arrows. The hot first air stream is supplied to the upper tool part 710 via the first supply line 811, preferably centrally. The air stream is supplied to a first annular section 712 via a preferably radially extending first intermediate space 711. The annular section 712 merges into an annular gap 713 towards the upper side. The first hot air stream is guided to the underside of the connecting ring 303 of the closure cap 300 via the annular gap 713.The connecting ring 303 is heated by the impinging hot first air stream so that the closure cap 300 can be welded to the bottle 200 in a next step. In particular, the connecting ring 303 is melted on its underside for this purpose. Preferably, the underside or front side is completely melted. The required melting temperature depends on the material.

[0090] Heating is contactless. The annular gap 713 does not come into contact with the connecting ring 303 during heating. The annular gap 713 forms a nozzle for specifically directing the first hot air stream onto the underside of the connecting ring 303. The annular gap 713 provides the first annular nozzle 713. For this purpose, the annular gap 713 has a cross-section that increases towards the top or air outlet side. In addition, the axis of the annular gap 713 is inclined outwards. This allows the air stream to be specifically directed onto the underside of the connecting ring 303 and then diverted to the outside. For this purpose, the first annular nozzle 713 is preferably formed by an inner wall that runs essentially vertically and by an oblique outer wall that is inclined towards the outside. The air stream is also deflected by the gap 305 formed between the inner ring 303 and the outer ring 304.

[0091] An extension of the inner wall of the annular gap 713 forms an upper inner ring 714 on the upper tool part 710. The raised inner ring 714 assists in guiding the air flow toward the underside of the connecting ring 303 of the cap 300. In order to additionally control and / or regulate the temperature of the first hot air flow, a section 715 surrounding the first annular nozzle 713, in particular a section of the first annular nozzle 713, can be additionally heated electrically. This allows heat loss of the first hot air flow in the upper tool part 710 to be at least partially compensated. For this purpose, a secondary electrical first heater 812 is provided. The power is supplied via line 813. The first, primary heating device 810 and the secondary heating device 812 can be controlled and / or regulated independently of one another, but can be coupled via a control loop.For example, increasing the secondary heating temperature increases the proportion of heat energy transferred by radiation. Conversely, reducing the temperature of the aforementioned first hot air stream reduces the proportion of heat energy transferred by convection. This represents an advantageous solution, particularly with regard to the thin-walled connecting ring 303 of the cap 300, and promotes local melting of the end face.

[0092] Figure 7.c shows the lower tool part 720, which is brought to the bottle 200 to be heated at a defined distance from the connecting flange 112. The lower tool part 720 is assigned the second heating device 820, via which a second hot air stream can be supplied to the lower tool part 720. The direction of the second hot air stream is indicated by arrows.

[0093] The hot second air stream is fed to the upper tool part 720 via the second supply line 821, preferably centrally. The air stream is fed to a second annular section 722 via a preferably radially extending second intermediate space 721. The annular section 722 merges into an annular nozzle 723 towards the underside. The second hot air stream is directed via the annular nozzle 723 onto the upper side of the connecting flange 112 on the bottle 200. The connecting flange 112 is heated by the impinging hot air stream so that the bottle 200 can be welded to the closure cap 300 in a next step. In particular, the connecting flange 112 is melted at its upper side, which forms a circular ring surface. Preferably, the upper side of the connecting flange 112 is completely melted. The required melting temperature depends on the material. The heating takes place without contact.The ring nozzle 723 does not come into contact with the connecting flange 112 during heating.

[0094] The second annular nozzle 723 directs the second hot air stream in a targeted direction towards the top side of the connecting flange 112. The axis of the second annular nozzle 723 is inclined inwards. This allows the air stream to be directed in a targeted direction towards the top side of the connecting flange 112 and then directed away to the outside. The air channel in the second annular nozzle is not directed vertically downwards, but rather inclined inwards. Thus, the air stream is also directed inwards. This allows the second hot air jet to be directed inwards towards the wall / connecting flange transition. There, the second air stream is deflected. This then flows along the top side of the connecting flange 112, heats it, and then flows away to the outside. The discharge of the air stream can also be supported by a recess 321 in the bottle gripper 320.

[0095] In order to be able to control and / or regulate the temperature of the second hot air stream, the second annular nozzle 723 can additionally be electrically heated, preferably in sections. This can at least partially compensate for heat loss from the second hot air stream in the lower tool part 720. For this purpose, a secondary electrical heater 822 is provided. The power is supplied via line 823. The second, primary heating device 820 and the secondary heating device 822 can be controlled and / or regulated independently of one another, but can be coupled via a control loop. Analogous to the upper tool part 710, the radiation- and convection-based components of the heat transfer can thus also be influenced here in order to bring the connecting flange 112 to the required surface temperature for welding sufficiently quickly and in a way that protects the material.The welding method and welding tool 700 according to the invention enable a reliable connection of the closure cap 300 to the container 200. An intimate connection is formed between the fused joining parts, i.e., between the connecting ring 303 on the closure cap 300 and the connecting flange on the container 200. The interior of the container 200 is hermetically sealed, in particular microbiologically tight, after the closure cap 300 is welded on.

[0096] It will be apparent to those skilled in the art that the described embodiments are to be understood as examples. The invention is not limited to these, but can be varied in many ways without departing from the essence of the invention. Features of individual embodiments and the features mentioned in the general part of the description can each be combined with one another or with one another.

[0097] Reference symbol:

[0098] 100 preforms

[0099] 110 First section of the preform

[0100] 111 First upper flange or guide flange

[0101] 112 Second lower flange or connecting flange

[0102] 113 First deepening

[0103] 114 Second deepening

[0104] 115 Opening or filling opening

[0105] 120 Second section of the preform

[0106] 130 Third section of the preform

[0107] 140 Fourth section of the preform

[0108] 145 Transition area

[0109] 146 notch

[0110] 150 hangers on the preform or container or fifth section of the preform

[0111] QH Transverse axis of the trailer L H Longitudinal axis of the hanger a Bending angle of the hanger (angle between the longitudinal axis of the hanger and the longitudinal axis of the preform)

[0112] 200 containers or bottles

[0113] 210 First section or bottle neck of the container

[0114] 220 Second section or shoulder area of ​​the container

[0115] 230 Third section or main body or bottle body of the container

[0116] 231 Curvature or shaped area on the container

[0117] 240 Fourth section or bottom area of ​​the container

[0118] 241 Stand

[0119] 250 Fifth area or hanger of the container

[0120] L Longitudinal axis of the preform and / or container

[0121] B First transverse axis along the width of the preform and / or the

[0122] container

[0123] T Second transverse axis along the depth of the preform and / or container

[0124] 300 closure or cap

[0125] 301 First access for taking a liquid

[0126] 302 Second access for adding a liquid

[0127] 303 Inner ring or connecting ring

[0128] 304 Outer ring or shielding ring

[0129] 305 Annular gap (between inner and outer ring

[0130] 310 cap gripper

[0131] 320 container gripper or bottle gripper

[0132] 321 Recess or ring groove on the bottle gripper

[0133] 700 welding tools

[0134] 710 Welding tool upper part or tool upper part

[0135] 711 First, preferably radially extending, intermediate space

[0136] 712 First annular section 713 First annular gap or first annular nozzle

[0137] 714 Electrically heated section

[0138] 715 guide ring

[0139] 720 welding tool base or tool base

[0140] 721 Second, preferably radially extending, intermediate space

[0141] 722 Second ring section

[0142] 723 Second ring nozzle

[0143] 724 Electrically heated section

[0144] 730 Mounting plate (if necessary with an upper and / or lower insulating layer)

[0145] 810 First (primary) heating device

[0146] 811 First hot air supply

[0147] 812 First secondary heating device

[0148] 813 First power supply

[0149] 820 Second (primary) heating device

[0150] 821 Second hot air supply

[0151] 822 Second secondary heating device

[0152] 823 Second power supply

[0153] S100 Preform preparation

[0154] S200 Heating and aligning the preform

[0155] S300 Bending the hanger

[0156] S400 Stretching and inflating the preform

[0157] S500 Clean and dry the container if necessary

[0158] S600 Filling the container

[0159] S700 Closing the container

[0160] S800 Sterilizing the container S900 Checking and / or labeling the container and / or arranging a plurality of containers in a carton and closing the

[0161] boxes

Claims

Patent claims:

1. A method for producing a container (200) filled with an infusion solution, comprising the following method steps: Providing a preform (100) with a hanger (150) arranged on a bottom of the preform (100) and a connecting flange (112) arranged in a head region of the preform (100) for welding to a closure cap, Heating the provided preform (100) in a heating device (10, 11, 12), Feeding the heated preform (100) into a stretching and inflating device (40), Stretching and inflating the preform (100) in the stretching and inflating device (40) so that the container (200) for the infusion solution is formed from the preform (100), Rinsing the molded container (200) and optionally drying the cleaned container (200) in a drying device, Filling the rinsed and optionally dried container (200) via a filling opening (115) provided in the container (200) with at least one infusion solution in a filling system, Providing a closure cap (300) for closing the container (200) with a connecting ring (303) arranged on an underside of the closure cap (300) for welding to the container (200), Heating a bottom side of the connecting ring (303) of the closure cap (300) and a top side of the connecting flange (112) of the container (220) formed from the preform (100) to a welding temperature, Closing the container (200) by applying the closure cap (300) to the filling opening (115) of the container (200) by pressing the heated underside of the connecting ring (303) of the closure cap (300) onto the heated upper side of the connecting flange (112) of the container (200) so that the closure cap (300) and the container (200) are firmly bonded to one another, Sterilizing the closed container (200) in an autoclave, characterized in that the upper side of the connecting flange (112) of the container (200) is heated at least in sections by a first hot air stream and the underside of the connecting ring (303) of the closure cap (300) is heated at least in sections by a second hot air stream, wherein the first hot air stream is guided through a preferably heated upper tool part (710) in the direction of the underside of the connecting ring (303) of the closure cap (200) and the second hot air stream is guided through a preferably heated lower tool part (720) in the direction of the upper side of the connecting flange (112) of the container (300).

2. Method according to the preceding claim, characterized in that the first hot air stream is directed through a first annular nozzle (713) in the upper tool part (710) is directed towards the underside of the connecting ring (303) of the closure cap (300) and / or that the second hot air stream is directed through a second ring nozzle (723) in the lower tool part (720) towards the top side of the connecting flange of the container (200).

3. Method according to one of the preceding claims, characterized in that the first annular nozzle (713) has a cross-section which increases towards an air outlet side and / or that the first annular nozzle (713) is inclined towards the outside.

4. Method according to one of the preceding claims, characterized in that the first annular nozzle (713) is formed by an inner wall which runs substantially vertically and by an oblique outer wall inclined towards the outside.

5. Method according to one of the preceding claims, characterized in that an axis of the second annular nozzle (723) is inclined inwards.

6. Method according to one of the preceding claims, characterized in that a temperature of the first hot air stream and a temperature of the second hot air stream can be adjusted, preferably regulated, independently of one another.

7. Method according to one of the preceding claims, characterized in that the upper tool part (710) and the lower tool part (720) can be heated independently of one another.

8. Method according to one of the preceding claims, characterized in that a temperature of the first annular nozzle (713) and a temperature of the second annular nozzle (723) can be adjusted, preferably regulated, independently of one another.

9. Method according to one of the preceding claims, characterized in that the first annular nozzle (713) and / or the second annular nozzle (723) can be electrically heated at least in sections.

10. Method according to one of the preceding claims, characterized in that the upper tool part (710) and the lower tool part (720) form a heating device and can only be moved together.

11. Method according to one of the preceding claims, characterized by checking the sterilized container (200) in an inspection device and / or applying a label to the checked container (200) and / or arranging a plurality of labeled containers (200) in a carton and closing the carton.

12. Plant for producing a container (200) filled with an infusion solution, comprising: A device for providing a preform (100), in particular with a hanger (150) arranged on a base of the preform (100), a heating device (10, 11, 12) for heating the provided preform (100), a device (40) for stretching and inflating the heated preform (100) so that the container (200) for the infusion solution can be formed from the preform (100), a device for rinsing the formed container (200) and optionally a device for drying the rinsed container (200), a filling system in which the rinsed and optionally dried container (200) can be filled with at least one infusion solution via a filling opening (15) provided in the container (200), a device for closing the container with a closure cap (300), an autoclave in which the closed container (200) can be sterilized,and wherein the device for closing the container (200) with the closure cap (300) comprises a hot-air welding tool, which is formed by an upper tool part (710) and a lower tool part (720), in which a first hot air stream can be guided through the, preferably heatable, upper tool part (710) in the direction of an underside of a connecting ring (303) of the closure cap (300) and a second hot air stream can be guided through the, preferably heatable, lower tool part (720) in the direction of an upper side of a connecting flange (112) on the container (300).

13. System according to the preceding claim, characterized by a first heating device (810) for providing the first hot air stream in the upper tool part (710) and by a second heating device (820) for providing the second hot air stream in the lower tool part (720), in particular wherein the first heating device (810) and the second heating device (820) are separately controllable and / or regulatable.

14. Installation according to one of the preceding claims, characterized in that the upper tool part (710) and the lower tool part (720) form a heating device and can only be moved together.

15. System according to one of the preceding claims, characterized in that the upper tool part (710) comprises a first annular nozzle (713) and / or the lower tool part (720) comprises a second annular nozzle (723), in particular wherein the first annular nozzle (713) is / are electrically heatable, at least in sections, by a first secondary heating device (812) and the second annular nozzle (723) is / are electrically heatable by a second secondary heating device (822).

16. Use of a system according to one of the preceding claims 12 to 15 for producing a container (200) filled with an infusion solution and closed with a closure cap (300).

17. Sterilized container (200) with a base body (230) stretched from a preform (100), inflated and filled with an infusion solution, which merges upwards via a shoulder region (220) into a bottle neck (210) with a filling opening (115) which is closed with a closure cap (300), and merges downwards into a base region (240), producible or produced by a method and / or using a system according to one of the preceding claims.

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